Label: LIDOCAINE HYDROCHLORIDE 2%- lidocaine injection

  • NDC Code(s): 57319-533-05, 57319-533-06
  • Packager: Clipper Distributing Company, LLC
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 17, 2013

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  • INDICATIONS & USAGE

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN


    INDICATIONS

    Lidocaine is a potent local anesthetic for producing epidural and nerve conduction anesthesia.

  • CONTRAINDICATIONS

    Lidocaine is contraindicated in animals with a known hypersensitivity to the drug.

  • PRECAUTIONS

    Lidocaine is usually well tolerated. Nevertheless, as with all local anesthetics, untoward effects may occur due to hypersensitivity, faulty technique, overdosage and inadvertent intravascular or subarachnoid injection. In case of respiratory arrest, immediate resuscitation with oxygen is indicated.

  • DOSAGE AND ADMINISTRATION

    Epidural
    Cattle
    and Horses - 5 to 15 mL
    Dogs and Cats
    - 1 mL per 10 pounds of body weight.
    Nerve Block
    Cattle
    and Horses
    - 5 to 20 mL
    Infiltration
    Dilute to 0.5% concentration (1 mL of 2% solution diluted with 3 mL of sterile water = 4 mL of a 0.5% solution)

  • COMPOSITION

    Each mL of sterile aqueous solution contains:
    Lidocaine Hydrochloride........................2.0%
    Propylene Glycol..................................5.2%
    Sodium Chloride...................................0.5%
    Sodium Lactate....................................0.5%
    with Methylparaben 0.15%, Sodium Metabisulfite 0.10%,
    Propylparaben 0.03%, and Disodium Edetate 0.001% as preservatives.
     

  • STORAGE AND HANDLING

    Store at controlled room temperature between 15o and 30oC (59o-86oF)

    TAKE TIME OBSERVE LABEL DIRECTIONS




  • PRINCIPAL DISPLAY PANEL



    Lidocaine Inj-13 Label
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HYDROCHLORIDE  2%
    lidocaine injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57319-533
    Route of AdministrationEPIDURAL, INFILTRATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.02 g  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57319-533-05100 mL in 1 BOTTLE
    2NDC:57319-533-06250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/31/2007
    Labeler - Clipper Distributing Company, LLC (150711039)